Title: Challenges to Quality and Regulatory Requirement in the United States—Drugs, Medical Device, and Cell Therapy
Abstract: Chapter 1 Challenges to Quality and Regulatory Requirement in the United States—Drugs, Medical Device, and Cell Therapy Chung Chow Chan, Chung Chow ChanSearch for more papers by this authorSultan Ghani, Sultan GhaniSearch for more papers by this authorIain Simpson, Iain SimpsonSearch for more papers by this authorJames Blakemore, James BlakemoreSearch for more papers by this author Chung Chow Chan, Chung Chow ChanSearch for more papers by this authorSultan Ghani, Sultan GhaniSearch for more papers by this authorIain Simpson, Iain SimpsonSearch for more papers by this authorJames Blakemore, James BlakemoreSearch for more papers by this author Book Editor(s):Chung Chow Chan, Chung Chow Chan CCC Consulting, Mississauga, Ontario, CanadaSearch for more papers by this authorKwok Chow, Kwok Chow Covar, Inc., Mississauga, Ontario, CanadaSearch for more papers by this authorBill Mckay, Bill Mckay Medtronic, Inc., Memphis, TN, USASearch for more papers by this authorMichelle Fung, Michelle Fung Gordon and Leslie Diamond Health Care Centre, University of British Columbia, Vancouver, British Columbia, CanadaSearch for more papers by this author First published: 22 August 2014 https://doi.org/10.1002/9781118903681.ch1Citations: 1 AboutPDFPDF ToolsRequest permissionExport citationAdd to favoritesTrack citation ShareShareShare a linkShare onFacebookTwitterLinked InRedditWechat Summary Recent breakthroughs in science and technology are transforming the ability to treat diseases and related regulatory challenges. Different therapeutic delivery solutions give different regulatory challenges for its approval. The development of regulatory science and new initiatives in FDA is intended to streamline compliance with current Good Manufacturing Practices (CGMP) and make effective medication available to the patients in a timely manner with the common goal of compliance to CGMP, although the detail process of achieving this goal is different. Expedited programs for serious conditions, greater availability of generic drugs, innovation pathway and guidances for combination products are discussed. Citing Literature Therapeutic Delivery Solutions RelatedInformation
Publication Year: 2014
Publication Date: 2014-08-22
Language: en
Type: other
Indexed In: ['crossref']
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Cited By Count: 1
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